Clinical Trial Monitoring by the KKS

 

Our service spectrum spans from specific individualized support in the details of planning, preparation and execution of a clinical trial, through the complete "soup to nuts" clinical trial execution including data management, and statistical analysis.

 

Planning

  • Conception and design of studies
  • Model based clinical trial planning
  • Systematic Reviews of randomized studies

 

Preparation

  • Summarizing the clinical trial protocol
  • Providing the CRF
  • Drafting of the text of the patient information and consent form
  • Planning up of the logistic operational flow
  • Examination of the feasibility (feasibility-study)
  • Application for private funding
  • Filings to the ethics commission (IRB) / Coordination of application to those involved at the ethics commission
  • Selection and coordination of possible trial centres
  • Coordination of suitable independent labs and other testing centres (e.g. central laboratory, radiology, pathology)
  • Organization and hosting of trial-related symposium
  • Registration/announcement of the clinical trial to the responsible authorities
  • Creation and care of data bases for all test centres

 

Computerization / Data Protection

  • Databases for clinical trials
  • Internet-connection (e.g. for Randomisation)

 

Data Management

  • Creation and managment of a Trial master file
  • Central Randomisations service
  • Monitoring of the data and flow of material
  • Plausibility and consistency testing
  • Doubled data input
  • further inquiries (Queries)
  • Reminders

 

Clinical monitoring

  • Regulation of type and range of monitoring
  • coordination of external monitors
  • Monitoring locally by KKSL monitors (for Investigator of initiates trials)

 

Statistic analysis and reporting

  • Statistic monitoring
  • Review of the protocol violations and overview of the collective analysis in coordination with the primary investigator
  • Analysis plan
  • Biometric evaluation/analysis report
  • Support with the presentation of scientific findings
  • Publication

 

 

 

Last updated: 13-Nov-2012